Food and Drug Administration (FDA)
NEWS
Nirmal Mulye, chief executive officer of Missouri-based Nostrum Laboratories, is looking to take over Martin Shkreli’s mantle of being the poster-boy for drastic drug price increases.
The U.S. Food and Drug Administration is hoping to fill numerous vacancies at the regulatory agency. In June, the FDA laid out some of its hiring needs, as well as its approach to attracting top-quality talent in a report to Congress.
Late-stage trial results show that a combination of Bavencio (avelumab) and Inlyta (axitinib) significantly improved progression-free survival in previously untreated patients with advanced renal cell carcinoma.
Shares of Indiana-based Endocyte have slipped more than 3 percent this morning after the company announced the U.S. Food and Drug Administration accepted radiographic progression-free survival as an alternative primary endpoint in its Phase III VISION trial.
Although the dominant story in biopharma patent litigation was the federal appeals court backing the Broad Institute of the Massachusetts Institute of Technology (MIT) and Harvard University over the University of California (UC) on CRISPR patents, there have been other patent decisions of note today as well. Let’s take a look.
Urovant Sciences, a Vivek Ramaswamy company under the Roivant umbrella, has filed for an initial public offering (IPO) to raise $150 million. It will list on Nasdaq under the UROV symbol.
In May the U.S. Food and Drug Administration approved Amgen’s preventative migraine treatment Aimovig. Amgen and its developmental partner Novartis, said the medication would be ready within one week for patients.
EpicGenetics and Massachusetts General Hospital (MGH) are launching a Phase II clinical trial to test a tuberculosis vaccine, BCG, as a potential treatment for fibromyalgia.
Amicus Therapeutics, headquartered in Cranbury, New Jersey, held a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding its regulatory path for AT-GAA for Pompe Disease. The company released its plans for the drug.
JOBS
IN THE PRESS